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目的对辅酶Q10水包油(O/W)型注射亚微乳进行处方设计并对其体内药动学进行研究。方法采用伪三元相图法研究不同表面活性剂、助表面活性剂及Km值下空白亚微乳体系的形成条件。优选亚微乳处方,制备载药亚微乳,并对其质量进行评价。通过静脉给药对辅酶Q10亚微乳大鼠体内药动学进行研究。结果泊洛沙姆/大豆磷脂/乙醇/聚乙二醇400形成的亚微乳黏度低,粒径小,包封率高。药动学实验表明,辅酶Q10亚微乳经静脉注射给药后具有明显的缓释作用,平均滞留时间6.55 h。结论经过优选的辅酶Q10亚微乳,辅料用量少,稳定性好,制备简单,便于生产及临床使用。
Objective To design a formulation of Coenzyme Q10 oil-in-water (O / W) injection submicroemulsion and study its pharmacokinetics in vivo. Methods The pseudo-ternary phase diagram was used to study the formation conditions of different surfactants, cosurfactants and blank submicron emulsion under Km value. The submicroemulsion prescription is preferred, the drug-loaded submicroemulsion is prepared, and the quality thereof evaluated. Pharmacokinetics of coenzyme Q10 submicron rat was studied by intravenous administration. Results Poloxamer / soybean lecithin / ethanol / polyethylene glycol 400 formed submicroemulsion viscosity, small particle size, high entrapment efficiency. Pharmacokinetic experiments show that coenzyme Q10 submicron emulsion after intravenous injection has a significant sustained-release effect, the average residence time of 6.55 h. Conclusion After the preferred coenzyme Q10 submicron emulsion, less excipients, good stability, simple preparation, ease of manufacture and clinical use.